Marina Sousa
Angestellt, Process Controller, LetsGetChecked
Bis 2022, Pharmaceuticals, Griffith College Dublin
Hamburg, Deutschland
Werdegang
Berufserfahrung von Marina Sousa
Bis heute 1 Jahr und 1 Monat, seit Mai 2023
Process Controller
LetsGetChecked
• Preparation and execution of validation plans, protocols and associated deviations • Participate in cross-functional and direct training of validation personnel by maintaining and improving validation SOPs, forms and training • Assembling of diagnostic kits and verification of BMRs • Support site Quality Management System (QMS) process as applicable (Change Controls, Documentation Management, CAPAs/NCRs, Audit Readiness, Supplier Quality Management).
7 Monate, Juni 2022 - Dez. 2022
Validation Engineer
Innopharma Technical Services
Work simulation program including developing, generating, and executing validation documentation in following areas: Cleaning Validation, Equipment & Utility qualification, Process Validation, Biopharma, Change Control and Investigated Non-Conformance’s and identified CAPA’s. Reviewed project documentation to ensure compliance of completed documentation.
Maintained and ensured compliance with the quality system application (ISO 9001, GMP) Managed Physical-chemical, metrological and sensorial analysis by monitoring performance activities associated with the raw materials and the final product (manufacturing, inspection, packaging, document review) Reviewed Corrective and Preventive Actions (CAPA) Conducted audits Provided non-conforming material investigation and improvement of processes Supported new SKU trials and first production
Responsible for developing and implementing Validation Master Plan activities Provided reports of the quality standard procedures Conducted effective internal audits of the plant-based on HACCP and Quality Management tools Controlled the management of Critical Equipment for Food Safety Improved by 4% the Microbiological Performance Indicators (Micro Index) by performing audits, processing information and taking appropriate action.
9 Monate, Apr. 2014 - Dez. 2014
Research Scientist
Fraunhofer-Institut für Fertigungstechnik und Angewandte Materialforschung IFAMDeveloped studies by analysing the activation of inorganic substrates through irradiation by vacuum ultraviolet light Improved the adhesion of PDMS-Urethane based on coatings Tested the application of coating through spin coating method Improved the understanding of characterization step, which consists of the superficial energy analysis, by the contact angle, of coating strength with the pull-off test and a cross-cut test
Ausbildung von Marina Sousa
1 Jahr und 4 Monate, Feb. 2021 - Mai 2022
Pharmaceuticals
Griffith College Dublin
9 Monate, Apr. 2014 - Dez. 2014
Materials Engineering
Universität Bremen
Undergraduate Exchange in Materials Engineering
6 Monate, Sep. 2013 - Feb. 2014
Chemical Engineering, Process Technology
Hochschule Anhalt
Undergraduate Exchange in Process Engineering
5 Jahre und 6 Monate, Feb. 2011 - Juli 2016
Chemical Engineering
Culture Collection of Catholic University of Pernambuco, Recife, Brazil
Sprachen
Portugiesisch
Muttersprache
Deutsch
Grundlagen
Englisch
Fließend